HYDROMORPHONE HYDROCHLORIDE solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)

متاح من:

Lannett Company, Inc.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Hydromorphone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2 )] , reserve hydromorphone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydromorphone hydrochloride oral solution is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions ( 5.7 )] Significant respiratory depression [see Warnings and Precautions ( 5.7 )] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautio

ملخص المنتج:

Hydromorphone Hydrochloride Oral Solution, USP is a clear, colorless liquid. It is available in: Bottles of 1 pint (473 mL): NDC 0527-1873-47 STORAGE : Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Store hydromorphone hydrochloride oral solution securely and dispose of properly [see Patient Counseling Information (17)] .

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Lannett Company, Inc.
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MEDICATION GUIDE
Hydromorphone Hydrochloride (hy-dro-MOR-fone hy-dro-KLOR-ide) Oral
Solution, USP, CII
Hydromorphone Hydrochloride Oral Solution is:
•
Strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require an opioid analgesic, when other pain
treatments such as non-opioid pain
medicines do not treat your pain well enough or you cannot tolerate
them.
•
Opioid pain medicine that can put you at risk for overdose and death.
Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse,
and misuse that can lead to
death.
Important information about Hydromorphone Hydrochloride Oral Solution:
•
Get emergency help right away if you take too much Hydromorphone
Hydrochloride Oral
Solution (overdose). When you first start taking Hydromorphone
Hydrochloride Oral Solution,
when your dose is changed, or if you take too much (overdose), serious
or life-threatening
breathing problems that can lead to death may occur.
•
Taking Hydromorphone Hydrochloride Oral Solution with other opioid
medicines,
benzodiazepines, alcohol, or other central nervous system depressants
(including street drugs) can
cause severe drowsiness, decreased awareness, breathing problems,
coma, and death.
•
Never give anyone else your hydromorphone hydrochloride oral solution.
They could die from
taking it. Selling or giving away hydromorphone hydrochloride oral
solution is against the law.
•
Store hydromorphone hydrochloride oral solution securely, out of sight
and reach of children, and
in a location not accessible by others, including visitors to the
home.
Do not take Hydromorphone Hydrochloride Oral Solution if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
Before taking Hydromorphone Hydrochloride Oral Solution, tell your
healthcare provider if you have a
history of:
•
head injury, seizures ● liver, kidney, thyroid p

خصائص المنتج

HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE SOLUTION
LANNETT COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROMORPHONE HYDROCHLORIDE
ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR HYDROMORPHONE
HYDROCHLORIDE ORAL SOLUTION.
HYDROMORPHONE HYDROCHLORIDE, USP ORAL SOLUTION, CII
INITIAL U.S. APPROVAL: JANUARY 1984
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK
EVALUATION
AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
HYDROMORPHONE HYDROCHLORIDE
ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG AND ML CAN
RESULT IN ACCIDENTAL OVERDOSE
AND DEATH. (2.1, 5.1)
HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION EXPOSES USERS TO RISKS OF
ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE
PRESCRIBING AND MONITOR REGULARLY
FOR THESE BEHAVIORS AND CONDITIONS. (5.2)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE,
THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION
AND MITIGATION STRATEGY
(REMS) FOR THESE PRODUCTS. (5.3)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.4)
ACCIDENTAL INGESTION OF HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION,
ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF HYDROMORPHONE. (5.4)
PROLONGED USE OF HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION DURING
PREGNANCY CAN RESULT IN
NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF
NOT RECOGNIZED AND TREATED. IF
PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE RISK OF NEO